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| ID | Type | Description | Link |
|---|---|---|---|
| SCIO-469ARA2003 | |||
| B007 |
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The primary objective of this study is to determine the efficacy of oral SCIO-469 in patients with rheumatoid arthritis who are not receiving liver damaging (hepatotoxic) disease-modifying anti-rheumatic drugs (DMARDs).
This is a 24 week randomized (study drug assigned by chance), double blind (neither physician nor patient knows the name of the assigned drug), placebo controlled, parallel group study assessing the safety and effectiveness of oral SCIO-469 in treating patients with rheumatoid arthritis who are not receiving liver damaging (hepatotoxic) disease-modifying anti-rheumatic drugs (DMARDs). The patient will participate in the study for approximately 183 days. Safety measures will include vital signs (blood pressure, pulse rate, breathing rate), 12-lead electro-cardiogram, adverse events, concomitant medications, and clinical laboratory evaluations (including serum chemistry, hematology, qualitative urinalysis, and liver function tests). The patient may be assigned to receive 30 mg capsule orally (by mouth) as one or two capsules three times daily, or receive 100 mg tablet orally once daily, or placebo (no active drug) orally as two capsules three times daily and placebo tablet orally once daily for 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental | SCIO-469 30 mg capsule three times daily for 12 weeks |
|
| 002 | Experimental | SCIO-469 60 mg capsule three times daily for 12 weeks |
|
| 003 | Experimental | SCIO-469 100 mg tablet once daily for 12 weeks |
|
| 004 | Placebo Comparator | Placebo 2 capsules three times daily and one tablet daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCIO-469 | Drug | 60 mg capsule three times daily for 12 weeks |
| |
| SCIO-469 |
| Measure | Description | Time Frame |
|---|---|---|
| ACR20 is 20% reduction in tender and swollen joint counts and 20% improvement in three of the five remaining ACR core set measures: patient and physician global assessments, visual analog scale for pain, HAQ, and an acute-phase reactant (CRP or ESR) | Day 1 to approximately Day 85 of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| ACR50 responders at Week 12 | 12 weeks | |
| ACR20 and ACR50 responders at each evaluation visit other than Week 12 | 24 weeks | |
| All individual variables of the ACR response criteria at each evaluation visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scios, Inc. Clinical Trial | Scios, Inc. | Study Director |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C499748 | SCIO-469 |
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| Drug |
30 mg capsule three times daily for 12 weeks |
|
| Placebo | Drug | 2 capsules three times daily and one tablet daily |
|
| SCIO-469 | Drug | 100 mg tablet once daily for 12 weeks |
|
| 24 weeks |
| Disease Activity Score (DAS)28 at each evaluation visit. | 24 Weeks |
| The number of participants experiencing adverse events (AEs) as a measure of safety | 24 weeks |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |